A randomised, double blind, placebo-controlled, multicentre study in asymptomatic HIV infected patients to investigate pharmacodynamics, pharmacokinetics, safety and toleration of UK-453,061

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-004120-39-DE
• Date of registration: 25/10/2005
• Prospective Registration: Yes
• Primary sponsor: Pfizer Pharma GmbH
• Public title: A randomised, double blind, placebo-controlled, multicentre study in asymptomatic HIV infected patients to investigate pharmacodynamics, pharmacokinetics, safety and toleration of UK-453,061
• Scientific title: A randomised, double blind, placebo-controlled, multicentre study in asymptomatic HIV infected patients to investigate pharmacodynamics, pharmacokinetics, safety and toleration of UK-453,061
• Date of first enrolment: 08/02/2006
• Target sample size: 28
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004120-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive
2. Weight between 50 and 100kg and within the permitted range for their height
using Quetelet's index-weight (kg)/height²(m). The permitted index is between
18-30
3. Patients with virus not containing NNRTI resistant mutations as determined by the
VircoGEN virtual phenotyping assay
4. No previous exposure to any NNRTIs
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Patients who on direct questioning and physical examination have any history of
convulsions or evidence of any clinically significant disease that in the opinion of
the investigator may impact on their participation in the study
2. Patients with a CD4 count <250cells/mm3
3. Patients whose HIV infection has been diagnosed <3 months prior to screening,
or for whom there is evidence of recent seroconversion
4. Patients with an HIV viral load <5000 copies/ml using RT-PCR (Roche Amplicor 1.5)
5. Patients with virus containing NNRTI-resistant mutations as determined by the
VircoGEN virtual phenotyping assay and in accordance with IAS resistance
guidelines (http://www.iasusa.org/resistance_mutations/index.html) or repeated
assay failure
6. Patients with AIDS or a previous AIDS diagnosis
7. Patients who are taking or have taken antiretroviral drugs in the eight weeks
prior to the study screening visit
8. Any patient, who in the opinion of the investigator, may need treatment with
antiretroviral drugs before the end of the study period
9. Patients with any clinically significant abnormality following review of pre-study
laboratory data and full physical examination apart from that which would be
expected as part of HIV infection. Specifically patients with evidence of hepatic
impairment (cut-off values of AST, ALT and AP >2.5 ULN, total bilirubin >2ULN and
albumin 10. Patients who are taking, or have taken, any prescribed or over the counter (with
the exception of paracetamol (up to 3g per day), multivitamins and minerals)
drugs in the three weeks prior to the first dose of study medication, except
those approved by the Pfizer CPM
11. Patients with a history of severe drug hypersensitivity reactions
12. Patients who drink more than 28 units of alcohol per week (1 unit = 1/2 pint of
beer [285mls] or 25ml of spirits or 1 glass of wine [125 mls])
13. Patients who have a psychological or sociological condition or an addictive
disorder that would preclude compliance with the protocol in the opinion of the
investigator
14. Patients who have received any experimental drug within the past four months
(prior to the first dosing day of the study) or who have previously received
another NNRTI


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

HIV
MedDRA version: 8 Level: PT Classification code 10020161

Intervention(s)

Product Name: UK-453,061
Pharmaceutical Form: Powder for oral suspension
Other descriptive name: 5-{[3,5-diethyl-1-(2-hydroxyethyl)-1H- pyrazol-4-yl]oxy}isophthalonitrile
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Powder for oral suspension
Route of administration of the placebo: Oral use

Product Name: UK-453,061
Pharmaceutical Form: Powder for oral suspension
Other descriptive name: 5-{[3,5-diethyl-1-(2-hydroxyethyl)-1H- pyrazol-4-yl]oxy}isophthalonitrile
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Powder for oral suspension
Route of administration of the placebo: Oral use

Product Name: UK-453,061
Pharmaceutical Form: Powder for oral suspension
Other descriptive name: 5-{[3,5-diethyl-1-(2-hydroxyethyl)-1H- pyrazol-4-yl]oxy}isophthalonitrile
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for oral suspension
Route of administration of the placebo: Oral use

Product Name: UK-453,061
Pharmaceutical Form: Powder for oral suspension
Other descriptive name: 5-{[3,5-diethyl-1-(2-hydroxyethyl)-1H- pyrazol-4-yl]oxy}isophthalonitrile
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Powder for oral suspension
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic HIV infected patients and to assess the dose-response relationship.
Assess the pharmacokinetics, safety and tolerability of UK-453,061 in asymptomatic HIV infected patients.

Primary end point(s): HIV viral load

Secondary Objective:

Secondary ID(s)

A5271010